Optimisation of incision hernia surgery treatment
| ISRCTN | ISRCTN45000842 |
|---|---|
| DOI | https://doi.org/10.1186/ISRCTN45000842 |
| Secondary identifying numbers | 73/2007 |
- Submission date
- 19/11/2007
- Registration date
- 04/03/2008
- Last edited
- 05/03/2008
- Recruitment status
- No longer recruiting
- Overall study status
- Completed
- Condition category
- Digestive System
Prospectively registered
Protocol
Statistical analysis plan
Results
Individual participant data
Record updated in last year
Plain English summary of protocol
Not provided at time of registration
Contact information
Dr Linas Venclauskas
Scientific
Scientific
Eiveniu str. 2
Kaunas
LT50009
Lithuania
Study information
| Study design | Blinded, randomised controlled trial |
|---|---|
| Primary study design | Interventional |
| Secondary study design | Randomised controlled trial |
| Study setting(s) | Hospital |
| Study type | Treatment |
| Scientific title | |
| Study objectives | 1. Open mesh repair hernia surgery is better than suture repair hernia surgery of incision hernia treatment 2. The recurrence rate using suture hernia repair technique is much higher than mesh repair technique 3. The recovering time to the normal physical activity after surgery is faster, quality of life is better using mesh repair with sublay technique than mesh repair with onlay technique or suture repair technique of the incision hernia treatment |
| Ethics approval(s) | Ethics approval received from Kaunas Biomedical Research Ethics Committee on the 5th June 2007 (ref: BE-2-41). |
| Health condition(s) or problem(s) studied | Hernia |
| Intervention | Three groups: 1. Keel technique 2. Onlay technique 3. Sublay technique The follow up period is 2 weeks, 1, 3, 6 and 12 months after surgery. Surgery, blood gas analysis and intra-abdominal pressure investigation before and after operation. |
| Intervention type | Other |
| Primary outcome measure | 1. Recurrence rate, measured at 2 weeks, 1, 3, 6 and 12 months after surgery 2. Quality of life, measured using the 36-item Short Form health survey version 2 (SF-36 v2)at 2 weeks, 1, 3, 6 and 12 months after surgery |
| Secondary outcome measures | 1. Postoperative complications, measured at 2 weeks, 1, 3, 6 and 12 months after surgery 2. Change of the blood gas and intra-abdominal pressure, measured before and after surgery 3. Recovering time to the normal physical activity after surgery, measured at 2 weeks, 1, 3, 6 and 12 months after surgery |
| Overall study start date | 01/07/2007 |
| Completion date | 01/07/2008 |
Eligibility
| Participant type(s) | Patient |
|---|---|
| Age group | Adult |
| Lower age limit | 18 Years |
| Sex | Both |
| Target number of participants | 50 patients in each group, 150 patients in all |
| Key inclusion criteria | All 18 - 80 years old patients with incision hernia, who will be operated and agree to participate in this clinical trial. |
| Key exclusion criteria | 1. Patients older than 80 years 2. Incarcerated incision hernia 3. Mental patients with incision hernia 4. Pregnant women with incision hernia 5. Patients with incision hernia do not agree to participate in this clinical trial |
| Date of first enrolment | 01/07/2007 |
| Date of final enrolment | 01/07/2008 |
Locations
Countries of recruitment
- Lithuania
Study participating centre
Eiveniu str. 2
Kaunas
LT50009
Lithuania
LT50009
Lithuania
Sponsor information
Kaunas Medical University Hospital (Lithuania) - Department of Surgery
Hospital/treatment centre
Hospital/treatment centre
Eiveniu str. 2
Kaunas
LT50009
Lithuania
| Website | http://www.kmu.lt/ |
|---|---|
"ROR" |
https://ror.org/0069bkg23 |
Funders
Funder type
Hospital/treatment centre
Kaunas Medical University Hospital (Lithuania) - Department of Surgery
No information available
Results and Publications
| Intention to publish date | |
|---|---|
| Individual participant data (IPD) Intention to share | No |
| IPD sharing plan summary | Not provided at time of registration |
| Publication and dissemination plan | Not provided at time of registration |
| IPD sharing plan |
